Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01124201
First received: May 13, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.


Condition Intervention
Chronic Low Back Pain
Other: Stabilization , strengthening and stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Pain (visual analogical scale and McGill pain questionnaire) [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
  • Functional disability (Oswestry disability questionnaire) [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
  • TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stabilization group
In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles.
Other: Stabilization , strengthening and stretching
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Other Name: Pressure Biofeedback Unit
Experimental: Strengthening group
In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles.
Other: Stabilization , strengthening and stretching
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Other Name: Pressure Biofeedback Unit
Experimental: Stretching group
Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles
Other: Stabilization , strengthening and stretching
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Other Name: Pressure Biofeedback Unit

Detailed Description:

Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.

Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.

Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.

  Eligibility

Ages Eligible for Study:   23 Years to 53 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • low back pain for more than 3 months
  • patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.

Exclusion Criteria:

  • past history of back surgery
  • rheumatologic disorders
  • spine infections
  • spine exercise training in the 3 months before study onset.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124201

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Fabio R França, MSc University of Sao Paulo
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fábio Jorge Renovato França, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01124201     History of Changes
Other Study ID Numbers: 1249/06
Study First Received: May 13, 2010
Last Updated: May 13, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
low back pain
clinical trial
stabilization
muscle stretching exercises
exercise therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014